• Section 2. Medical Errors Prevalence, Definitions & Root Cause Analysis

    Medical Errors Prevalence

    AmbulanceThe 1999 report by the Institute of Medicine found that up to 98,000 Americans die every year from preventable medical errors made in hospitals alone. In fact, there are more deaths in hospitals each year from preventable medical mistakes than there are from vehicle accidents, breast cancer, and AIDS.

    This call to action to reduce preventable medical mistakes lead to the formation of the Leapfrog Group, an independent, national nonprofit organization that administers the Hospital Safety Score Report. The Leapfrog Group, an advocate for patient safety nationwide, realized that they could take ‘leaps’ forward with their employees, retirees, and families by rewarding hospitals that achieve significant improvements in quality and safety.3

    The Leapfrog Group Hospital Safety Score assigns A, B, C, D and F grades to more than 2,500 U.S. general hospitals. It shows many hospitals are making headway in addressing errors, accidents, injuries and infections that kill or hurt patients, but overall progress is slow.4

    New research released by the Leapfrog Group in their Hospital Safety Score Report, estimates that up to 440,000 Americans are dying annually from preventable hospital errors alone. This puts medical errors as the third leading cause of death in the United States, underscoring the need for patients to protect themselves and their families from harm, and for hospitals to make patient safety a priority.5

    The Report notes that many hospitals in this country have safety records that wouldn’t be tolerated in any other industry. The statistics are alarming:6

    • As many as 440,000 people die every year from hospital errors, injuries, accidents, and infections
    • Every year, 1 out of every 25 patients develops an infection while in the hospital—an infection that didn’t have to happen
    • A Medicare patient has a 1 in 4 chance of experiencing injury, harm or death when admitted to a hospital
    • Today alone, more than 1000 people will die because of a preventable hospital error

    “We are burying a population the size of Miami every year from medical errors that can be prevented. A number of hospitals have improved by one or even two grades, indicating hospitals are taking steps toward safer practices, but these efforts aren’t enough,” says Leah Binder, president and CEO of Leapfrog. “During this time of rapid healthcare transformation, it’s vital that we work together to arm patients with the information they need and tell doctors and hospitals that the time for change is now.”

    If all urban hospitals implemented just the first three of Leapfrog’s four original “leaps” (evidence-based safety and quality standards), over 57,000 lives could be saved, more than 3 million medication errors could be avoided, and up to $12 billion could be saved each year.7

    However, one of the Reports key findings was that on average, there was no improvement in hospitals’ reported performance on the measures included in the score, with the exception of hospital adoption of computerized physician order entry (CPOE). The expansion in adoption of this lifesaving technology suggests that federal policy efforts to improve hospital technology have shown some success.

    Medical Errors Terms & Definitions

    The Institute of Medicine (IOM) provides definitions of key terms so that a standard framework can be used for discussing issues related to medical errors and patient safety:8

    Medical Error - the failure to complete a planned action as intended or the use of a wrong plan to achieve an aim. Errors can include problems in practice, products, procedures, and systems.

    The Food and Drug Administration (FDA) defines an adverse event as any undesirable experience associated with the use of a medical product on a patient.

    Adverse Event - an injury caused by medical management rather than by the underlying disease or condition of the patient.

    The adverse event is deemed SERIOUS and should be reported when the patient outcome is:9

    Death - Report if the patient's death is suspected as being a direct outcome of the adverse event.

    Life Threatening - Report if the patient was at substantial risk of dying at the time of the adverse event or if it is suspected that the use or continued use of the product would result in the patient's death.

    Hospitalization (initial or prolonged) - Report if admission to the hospital or prolongation of a hospital stay is a result of the adverse event.

    Disability - Report if the adverse event resulted in a significant, persistent, or permanent change, impairment, damage or disruption in the patient's body function/structure, physical activities or quality of life.

    Congenital Anomaly - Report if there are suspicions that exposure to a medical product prior to conception or during pregnancy resulted in an adverse outcome in the child.

    Requires Intervention to Prevent Permanent Impairment or Damage - Report if suspected that the use of a medical product resulted in a condition, which required medical or surgical intervention to preclude permanent impairment or damage to a patient.

    Some adverse events are not preventable and they reflect the risk associated with treatment, such as a life-threatening allergic reaction to a drug when the patient had no known allergies to it. However, the patient who receives an antibiotic to which he or she is known to be allergic, goes into anaphylactic shock, and dies, represents a preventable adverse event.

    Preventable Adverse Event - an adverse event that was attributable to a medical error. Negligent adverse events represent a subset of preventable adverse events that satisfy legal criteria used in determining negligence: whether the care provided failed to meet the standard of care reasonably expected of an average physician who is deemed qualified to take care of the patient in question.

    Root Cause Analysis & Action

    According to the National Patient Safety Foundation, “Millions of patients in the United States are harmed every year as a result of the healthcare they receive.” In response to this problem the National Patient Safety Foundation has recommended practices to improve the manner in which one can learn from adverse events and unsafe conditions, and take action to prevent their occurrence in the future.10

    Traditionally, the process employed to accomplish this learning has been called Root Cause analysis (RCA), but it has had inconsistent success. To improve the effectiveness and utility of these efforts, the National Patient Safety Foundation has concentrated on the ultimate objective: preventing future harm.

    Prevention requires actions to be taken, and so they have renamed the process Root Cause Analysis and Action, RCA2 (RCA “squared”) to emphasize this point. The purpose is to ensure that efforts undertaken in performing RCA2 will result in the identification and implementation of sustainable systems-based improvements that make patient care safer in settings across the continuum of care. The approach is two-pronged.

    The first goal is to identify methodologies and techniques that will lead to more effective and efficient RCA2.

    The second is to provide tools to evaluate individual RCA2 reviews so that significant flaws can be identified and remediated to achieve the ultimate objective of improving patient safety.

    Just as a well-performed and well-executed RCA2 must take a systems-based approach, the same approach is important in formulating a methodology that will achieve these desired objectives. The success of any patient safety effort lies in its integration into the fabric of the organization at all levels. This cannot happen without the active participation of leaders and managers at all levels

    The purpose of an RCA2 review is to identify system vulnerabilities so that they can be eliminated or mitigated. RCA2 processes are not to be used to focus on or address individual healthcare worker performance as the primary cause of an adverse event, but instead to look for the underlying systems-level causations that were manifest in personnel-related performance issues. Findings from an RCA2 must not be used to discipline, shame, or punish staff.

    It is critical that each organization define blameworthy events and actions that will be handled or dealt with using administrative or human resource systems.

    To be effective, a risk-based prioritization system must receive reports of adverse events, close calls, hazards, or system vulnerabilities from staff. Not receiving reports can negatively impact the ability to estimate the probability that an event or hazard may occur.

    A root cause analysis will be considered acceptable by the Joint Commission on Accreditation of Health Care Organizations if it has the following characteristics: 11

    • The analysis focuses primarily on systems and processes, not on individual performance
    • The analysis progresses from special causes in clinical processes to common causes in organizational processes
    • The analysis repeatedly digs deeper by asking “Why?”; then, when answered, “Why?” again, and so on
    • The analysis identifies changes that could be made in systems and processes (either through redesign or development of new systems or processes) that would reduce the risk of such events occurring in the future
    • The analysis is thorough and credible

    CASE STUDY #1

    After completing the next Case Study, go to the "Section 3" in the Navigation Bar to continue through the course.

Section 1. Course Objectives and Reducing Medical ErrorsSection 3. Common Medical Errors